Recapping a Year of FDA Regulations on Digital Healthcare Tech


Last year, the FDA put a considerable amount of energy into the digital health technology approval process. Will these efforts carry into 2018?

2017 was an exciting year for digital health. We saw a host of new ventures to improve quality of care, the beginnings of the fully digital clinical trial, and immediate evidence of cost savings from this technology.

But one of the stars of this digital health revolution was Dr. Scott Gottlieb, the new FDA commissioner, who has an innovative and supportive agenda toward digital health technology. Here’s how his regulatory decisions shaped 2017, and how they’ll continue to affect the industry this year as well:

Chasing the Future of Digital Health

Gottlieb has already taken proactive measures to create progress on digital health. Roughly a month after his confirmation, Gottlieb published a blog post outlining the guidelines his agency would follow for approving and regulating new digital health devices. And change came quickly – soon after, the FDA released its Digital Health Innovation Action Plan, indicating its intention to restructure its processes to accommodate for quicker innovation.

Part of this plan is a pilot for a firm-focused pre-certification program, which opened in July to nine companies with strong digital health offerings. Once approved, these companies would be subject to relaxed regulations surrounding new devices, making it easier to iterate and update devices without additional time for approval. The FDA has also stated that the same process will soon be applied to direct-to-consumer genetic health risk tests from companies like 23andMe.

Other announcements in 2017 supported Gottlieb’s vision of a streamlined, common-sense approval process for digital health devices. They included a handful of new guidelines on clinical decision support, changes to the 21st Century Cures Act that allow more device categories to stay outside of FDA regulation, and a draft guidance that expedites the clearance process for novel technologies that present a significant improvement to the status quo.

What Does This Mean for 2018?

Gottlieb’s FDA clearly prioritized digital health innovation in 2017, and we believe this trend will continue into 2018. The FDA recognizes the value that digital health can bring to our healthcare system, as well as the benefits it can bestow upon patients and providers. The agency is actively working to simplify the pathway to approval for many of these technologies, and has indicated that, beyond health and safety concerns, it will not stand in the way of new technology that saves lives and reduces costs of medical care.

In a more recent blog post, Gottlieb discussed his 2018 goals for the agency, stating that, although new advances present new challenge in regulation, he believes the FDA needs to adapt its customary approaches. He hopes to instill a new policy framework for diagnostic testing, allowing them to be reviewed by third parties and reducing the burden on developers. In 2018, the FDA will also continue to promote transparency for patients and streamlined regulatory processes for new technologies, including 3D printed devices and regenerative medicine.

The FDA has all but paved the road to a fully enabled digital future. We’re excited to see what new innovations 2018 will bring.

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